On June 21, 2019, Bill C-97 received Royal Assent. Bill C-97 includes amendments to the Food and Drugs Act, including a new framework for “Advanced Therapeutic Products”, and will come into force on a day to be fixed. On July 18, 2019, Health Canada opened a consultation seeking feedback on what Health Canada should consider in developing new clinical trial regulations, as well as implementing the pathway for Advanced Therapeutic Products. The consultation will close on August 30, 2019.